FDA.reportPublic FDA data

easyEndoTM Lite Loading Unit for Single Use

Primary DI
06925776102496
Brand
easyEndoTM Lite Loading Unit for Single Use
Company
Ezisurg Medical Co., Ltd.
Model
N60M
Catalog number
N60M
Device description
Lite Loading Unit, 60mm long, staple height 2.0mm, grey
Published
2021-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDWStaple, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210909000easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.2021-06-24GDW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
66925776102498PackageGS16In Commercial Distribution
76925776102495PackageGS13Not in Commercial Distribution
06925776102496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
6692577610249866925776102498
7692577610249576925776102495
06925776102496069257761024966925776102496

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
421348845
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06925776121404easyEndoTM E-Lite Single Use CartridgesPN45TPN45T2026-10-26
06925776121428easyEndoTM E-Lite Single Use CartridgesPN60TPN60T2026-10-26
06925776106050easyEndoTM E-Lite Single Use CartridgesPN60MPN60M2026-10-21
06925776106067easyEndoTM E-Lite Single Use CartridgesPN60WPN60W2026-10-21
06925776106074easyEndoTM E-Lite Single Use CartridgesPN60BPN60B2026-10-21
06925776106081easyEndoTM E-Lite Single Use CartridgesPN60CPN60C2026-10-21
06925776106098easyEndoTM E-Lite Single Use CartridgesPN60GPN60G2026-10-21
06925776106104easyEndoTM E-Lite Single Use CartridgesPN45MPN45M2026-10-21
06925776106111easyEndoTM E-Lite Single Use CartridgesPN45WPN45W2026-10-21
06925776106128easyEndoTM E-Lite Single Use CartridgesPN45BPN45B2026-10-21
06925776106135easyEndoTM E-Lite Single Use CartridgesPN45CPN45C2026-10-21
06925776106142easyEndoTM E-Lite Single Use CartridgesPN45GPN45G2026-10-21
06925776121923easyEndoTM E-Lite Single Use Powered Endoscopic StaplersP2UL45P2UL452026-10-21
06925776121930easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipP2UL45GP2UL45G2026-10-21
06925776121947easyEndoTM E-Lite Single Use Powered Endoscopic StaplersP2UL60P2UL602026-10-21
06925776121954easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipP2UL60GP2UL60G2026-10-21
06925776121961easyEndoTM E-Lite Single Use Powered Endoscopic StaplersP2UM45P2UM452026-10-21
06925776121978easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipP2UM45GP2UM45G2026-10-21
06925776121985easyEndoTM E-Lite Single Use Powered Endoscopic StaplersP2UM60P2UM602026-10-21
06925776121992easyEndoTM E-Lite Single Use Powered Endoscopic Staplers with Curved TipP2UM60GP2UM60G2026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06925776121404easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-26
06925776121428easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-26
06925776106050easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106067easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106074easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106081easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106098easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106104easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106111easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106128easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106135easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
06925776106142easyEndoTM E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.GDW2026-10-21
10884521703827Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703841Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703858Tri-Staple 2.0Covidien LPGDW2026-08-09
10884521703797Tri-Staple 2.0Covidien LPGDW2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGDW2026-07-31
16953886000033TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000040TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000057TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000064TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000071TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000088TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000095TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000101TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000330TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000347TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000354TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27
16953886000408TOUCHSTONETouchstone International Medical Science Co., Ltd.GDW2026-07-27